A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria include:
Males and females ≥18 years of age
Subjects with IDA
Subjects who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study
Key Exclusion Criteria include:
History of allergy to IV iron
Allergy to two or more classes of drugs
Subjects on dialysis or with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
Female subjects who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test